Expanded Clinical Study of the Tendyne Mitral Valve System

Mitral Valve Regurgitation Clinical Trial

Official title:

Expanded Clinical Study of the Tendyne Mitral Valve System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02321514
• Other study ID #: CS-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 191
• Est. completion date: December 2025
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Severe mitral regurgitation of primary or secondary etiology according to MVARC

(Mitral Valve Academic Research Consortium) 2015 defined as:

• For Degenerative MR: EROA = 40 mm^2 or regurgitant volume = 60ml
• For Secondary MR: EROA = 20 mm^2 or regurgitant volume = 30ml

2. New York Heart Association (NYHA) functional Class = II while on guideline directed medical therapy (GMDT), including device therapy (CRT) if indicated.

3. Heart team determines patient is not a suitable candidate for traditional surgical treatment according to valid guidelines.

4. Age 18 years or older.

Exclusion Criteria:

1. Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.

2. Left Ventricle (LV) or Left Atrium (LA) thrombus.

3. Patient has a chest condition that prevents transapical access.

4. Left ventricular ejection fraction (LVEF) less than 30% by echocardiogram.

5. Left Ventricular End Diastolic Diameter (LVEDD) > 7.0 cm.

6. Prior surgical or interventional treatment of mitral or aortic valves (e.g. valve repair or replacement, MitraClip, edge to edge repair, aortic balloon valvuloplasty, etc.).

7. Any planned surgery or interventional procedure within the period of 30 days prior to 30 days following the implant procedure. This includes any planned concomitant cardiovascular procedure such as PCI, pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.

8. Cardiac resynchronization therapy device or implantable pulse generator implanted within three months of planned implant procedure.

9. Myocardial Infarction (MI) within 30 days of the planned implant procedure.

10. Symptomatic, unresolved multi-vessel coronary artery disease (CAD) or unprotected left main coronary artery disease requiring stenting or Coronary Artery Bypass Grafting (CABG).

11. Cerebrovascular accident (CVA) within six months of planned implant procedure.

12. Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound).

13. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.

14. Severe tricuspid regurgitation, tricuspid valve disease requiring surgery or severe right ventricular dysfunction.

15. Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.

16. Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated.

17. History of endocarditis within six months of planned implant procedure.

18. Active systemic infection requiring antibiotic therapy.

19. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anti-coagulation therapy) which cannot be adequately managed medically or hypersensitivity to nickel or titanium.

20. Patient is undergoing hemodialysis due to chronic renal failure.

21. Patient has pulmonary arterial hypertension (fixed PAS >70mmHg).

22. Patient has COPD and is on home oxygen.

23. Patient refuses blood transfusions.

24. Pregnant, lactating, or planning pregnancy within next 12 months.

25. Participating or planning participation in an investigational drug or another device study.

26. Patient or legal guardian unable or unwilling to give informed consent.

27. Patient unable or unwilling to comply with study required testing and follow-up visits.

28. Patients with non-cardiac co-morbidities that are likely to result in a life expectancy of less than one year.

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• Tendyne Mitral Valve System
Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system

Locations

Country	Name	City	State
Australia	Flinders Medical Center	Bedford Park
Australia	Prince Charles Hospital	Chermside
Australia	St. Vincent's Hospital	Sydney
France	Bordeaux University Hospital	Bordeaux
France	CHRU de Lille	Lille
France	Lyon University Hospital	Lyon
France	Rennes University Hospital	Rennes
France	Clinique Pasteur	Toulouse
Germany	Deutsche Herzzentrum Berlin	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	University Hospital Dresden	Dresden
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	University Heart Center Hamburg	Hamburg
Germany	Leipzig Heart Center	Leipzig
Germany	University of Munich	Munich
Italy	Ospedale Ferrarotta - Catania	Catania
Italy	San Raffaele	Milan
Italy	Pisa University	Pisa
Italy	Humanitas Research Hospital	Rozzano
Italy	San Donato	San Donato Milanese
Netherlands	St. Antonius Hospital	Nieuwegein
Norway	Oslo University Hospital	Oslo
Sweden	Karolinksa University Hospital	Solna
Switzerland	University Hospital of Zurich	Zürich
United Kingdom	Royal Brompton Hospital	London
United States	Emory University Hospital	Atlanta	Georgia
United States	Baylor Heart & Vascular Center	Dallas	Texas
United States	Delray Medical Center	Delray Beach	Florida
United States	Henry Ford Hospital	Detroit	Michigan
United States	Northshore University Health System	Evanston	Illinois
United States	Pinnacle Health - Harrisburg Hospital	Harrisburg	Pennsylvania
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	West Virginia University	Morgantown	West Virginia
United States	Honor Health Scottsdale Shea Medical Center	Scottsdale	Arizona
United States	MedStar Washington Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Italy,  Netherlands,  Norway,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Endpoint: Number of Participants With Composite of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs)	Device success and freedom from the following device- or procedure-related serious adverse events (SAEs) at 30 days post the index procedure, will be classified by the Clinical Events Committee (CEC): Cardiovascular death; Reintervention caused by valve-related dysfunction; Disabling stroke; Myocardial infarction (MI); Life-threatening bleeding (BARC Type 2, 3, and 5); Major Vascular Complications; Renal failure requiring dialysis; Other device-related SAEs; Other procedure-related SAEs	30 days post-index procedure
Primary	Performance Endpoint: Number of Participants With MR Grade = 2	Proportion of subjects with mitral regurgitation (MR) grade = 2, per echocardiography core laboratory will be assessed.; MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.	30 days post-index procedure